Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06416410 | JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation | PHASE3 | RECRUITING | 392 | — | — | Aug 7, 2024 | Feb 28, 2027 | Apr 4, 2025 | 37 | China |
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC).
| Arm | Type | Description |
|---|---|---|
| JAB-21822+JAB-3312 | EXPERIMENTAL | JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle |
| Tislelizumab combined with Pemetrexed + Carboplatin | ACTIVE_COMPARATOR | Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle |
| Name | Type | Description |
|---|---|---|
| JAB-21822 | DRUG | JAB-21822 administered orally as a tablet |
| Tislelizumab | DRUG | Tislelizumab administered as an intravenous (IV) infusion |
| JAB-3312 | DRUG | JAB-3312 administered orally as a tablet or capsule |
| Pemetrexed | DRUG | Pemetrexed administered as an intravenous (IV) infusion |
| Carboplatin | DRUG | Carboplatin administered as an intravenous (IV) infusion |
Inclusion Criteria: * A signed written informed consent is required before performing any study-related operations * Age greater than or equal to 18 years old * Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirme...